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FDA 510(k)

BIOK7600 Flat Panel Detector

K-Number: K190311 · 2019-03-13

ApplicantBiokinemetrics, Inc.
Decision Date2019-03-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOK7600 Flat Panel Detector is the device name listed in this FDA 510(k) record. The listed applicant is Biokinemetrics, Inc.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K190311. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOK7600 Flat Panel Detector?

BIOK7600 Flat Panel Detector is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Biokinemetrics, Inc.. The 510(k) number is K190311.

When did BIOK7600 Flat Panel Detector receive FDA 510(k) clearance?

BIOK7600 Flat Panel Detector received FDA 510(k) clearance on 2019-03-13, under 510(k) number K190311.

Who is the listed applicant for BIOK7600 Flat Panel Detector?

The FDA 510(k) record lists Biokinemetrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOK7600 Flat Panel Detector?

The FDA product code for BIOK7600 Flat Panel Detector is MQB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07092553Evaluation of C-arm PCD-CBCT for Image-Guided InterventionsNOT_YET_RECRUITING

Other records listing Biokinemetrics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190300BIOK7600W Wireless Flat Panel DetectorK181565Aquarius 8600 Digital Radiography Sensor

Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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